• Cover letter, signed by the PI (template)
  • EC application form, signed (most recent version)
  • Clinical Trial Application Form
    (if Ghent University (Hospital) does not act as the sponsor of the trial; otherwise provided by HIRUZ CTU)
  • Protocol
  • Protocol summary
  • Informed Consent Form(s)
  • All documents provided to the subjects
    (e.g. recruitment material, flyers, posters, diaries, questionnaires, interview topic list, patient trial cards…)
  • IB, SmPC, IMPD of the IMP(s)
  • Secondary label(s) for the IMP(s)
  • GMP-certificate (if applicable)
  • Data processing register (Ghent University Hospital studies | Ghent University studies)
  • Agreements
    (if applicable – a draft version is sufficient)
  • CV and GCP certificate of the PI at Ghent University (Hospital)
  • CVs and GCP certificates of all local PIs
    (if applicable – in case of a multicentric study)
  • Insurance certificate
    (only if Ghent University (Hospital) does not act as the sponsor of the study; otherwise provided by HIRUZ CTU)
  • Letter of approval from the FAMHP
    (only if Ghent University (Hospital) does not act as the sponsor of the study and if applicable yet)